Associate Validation Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as an Associate Validation Engineer. You will contribute to the development and execution of validation protocols for various processes, ensuring GMP compliance and operational excellence. Responsibilities include generating and executing life cycle documentation, writing reports, performing walkdowns and thermal mapping, and supporting regulatory compliance. The ideal candidate possesses a Bachelor's degree in a related life science field and 1-3 years of experience in the biotech/pharmaceutical industry. Strong communication, organizational, and collaborative skills are essential. Syner-G offers a competitive salary, robust benefits, flexible work options, and career development opportunities.

Requirements

• Bachelor’s degree in a related life science field
• 1-3 years of experience within the biotech, pharmaceutical, or medical device industry
• Understanding of GMP regulations and their application in a manufacturing environment
• Ability to work collaboratively with cross-functional teams to achieve operational goals
• Strong organizational skills and attention to detail

Responsibilities

• Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification
• Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)
• Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities
• Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments
• Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
• Support the resolution of regulatory observations or manufacturing site issues
• Execute periodic reviews and requalification for temperature chambers
• Ensure all validation activities comply with GMP regulations and internal quality standards
• Collaborate with operations and quality teams to ensure seamless integration of validation activities into daily operations
• Assist in the development and implementation of GMP training programs for staff to ensure compliance and operational excellence
• Monitor and report on validation activities to ensure timely completion and adherence to project timelines
• Participate in continuous improvement initiatives to enhance GMP compliance and operational efficiency

Preferred Qualifications

• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis
• Basic understanding of validation in Equipment, CSV, Method, and Process
• Some experience with protocol generation for automated production systems, with a focus on computerized equipment and systems validation
• Basic report writing experience for IQ, OQ, PQ, and CSV
• Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”